標(biāo)準(zhǔn)編號(hào):	YY 0307-2011
中文名稱:	連續(xù)波摻釹釔鋁石榴石激光治療機(jī)
英文名稱:	Nd:YAG laser medical instrument with continuous wave(CW)
中標(biāo)分類:	C41    醫(yī)用超聲、激光、高頻儀器設(shè)備
行業(yè)分類:	YY    醫(yī)藥行業(yè)標(biāo)準(zhǔn)
ICS分類:	11.040.60 11.040.60    治療設(shè)備 11.040.60
發(fā)布機(jī)構(gòu):	國(guó)家食品藥品監(jiān)督管理局
發(fā)布日期:	2011-12-31
實(shí)施日期:	2013-6-1
標(biāo)準(zhǔn)狀態(tài):	superseded
被新標(biāo)準(zhǔn)替代:	YY 0307-2022 激光治療設(shè)備 摻釹釔鋁石榴石激光治療機(jī)
被替代日期:	2025-6-1
翻譯語言:	英文
文件格式:	PDF
中文字符數(shù):	14000 字
翻譯價(jià)格(元):	980.0
交付時(shí)間:	付款后 1 個(gè)工作日

1 Scope This standard specifies the definition, basic parameters, requirements, test methods, sampling, mark, label, packaging, etc. of Nd: YAG laser medical instrument with continuous wave. This standard is applicable to Nd: YAG laser medical instrument with continuous wave with wavelength of 1064nm (hereinafter referred to as medical instrument). Medical instrument is able to coagulate, vaporize, carbonize and melt tissue. 2 Normative References The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the reference document (including any amendments) applies. GB/T 191 Packaging - Pictorial Marking for Handling of Goods GB 7247.1 Safety of Laser Products - Part 1: Equipment Classification, Requirements and User's Guide GB 9706.1 Medical Electrical Equipment - Part 1: General Requirements for Safety GB 9706.19-2000 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Endoscopic Equipment GB 9706.20 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment GB/T 14710-2009 The Environmental Requirement and Test Methods for Medical Electrical Equipment GB/T 17736-1999 Testing Method of Main Parameters for Laser Protective Eyewear YY/T 0758 General Requirements for Therapeutic Laser Fiber YY 91057-1999 General Specifications for Medical Foot Switch ISO 11146 Lasers and Laser-related Equipment - Test Methods for Laser Beam Widths, Divergence Angles and Beam Propagation Ratios 3 Term, Definition and Symbols 3.1 Term and Definition

Foreword I 1 Scope 2 Normative References 3 Term, Definition and Symbols 4 Composition and Basic Parameters 5 Requirements 6 Test Methods 7 Inspection Rules 8 Mark, Label and Operating Instructions 9 Packaging, Transportation and Storage